Integrated blood treatment module and extracorporeal blood treatment apparatus

ABSTRACT

The invention relates to an integrated blood treatment module ( 1 ) comprising a support element ( 4 ) and a fluid distribution circuitry associated thereto; the distribution circuitry comprises at least a blood line ( 44 ), a portion of which is secured to the support element and defines with the latter at least a U-shaped tube length ( 44   a ) designed to cooperate, when in use, with a respective pump ( 3   a ). There are then further fluid lines ( 45, 48, 50, 51 ) fastened to the support element and defining each at least a U-shaped tube length ( 45   a   , 48   a   , 50   a   , 51   a ) with respect to said element and each designed to cooperate, when in use, with a respective pump ( 3   b   , 3   c   , 3   d   , 3   e ). The support element has a first zone ( 274 ) in which the portion of the blood line is secured, and at least a second zone ( 275 ) opposite said first zone, to which all the corresponding further tube lengths are fastened.

BACKGROUND OF THE INVENTION

[0001] The present invention relates to an integrated blood treatmentmodule and to an extracorporeal blood treatment apparatus that canreceive said integrated module.

[0002] As is known, in order to carry out extracorporeal bloodtreatments such as for instance haemodialysis, haemofiltration,haemodiafiltration, plasmapheresis, extracorporeal blood oxygenation,extracorporeal blood filtration or other treatments, it is necessary toprovide for at least an extracorporeal circuit through which the bloodflows and is conveyed towards a treatment unit; the treated blood isthen carried back to the patient's cardiovascular system. Referring byway of example to a dialysis treatment, the extracorporeal circuit usedcomprises: a dialysis filter consisting of a housing body defining atleast a first and a second chamber separated from each other by asemipermeable membrane, a blood intake line leading to the first chamberof the dialysis filter and a blood return line designed to receive bloodcoming out of the first chamber and to carry it back to the patient. Thesecond chamber of the dialysis filter is then connected to a circuit forthe circulation of a dialysis liquid designed to receive the impuritiesthat are present in the blood and the excess fluid that has to beremoved from the patient's blood.

[0003] Currently, in apparatus for extracorporeal blood treatments allthe lines designed for the circulation of the dialysis liquid are housedwithin the dialysis apparatus, whereas the lines constituting theextracorporeal blood circuit are replaced at every treatment andsuitably connected to the dialyzing filter, which can be replaced eitherat every treatment or from time to time, as required.

[0004] From a structural point of view the dialysis filter, the linesfor the circulation of the dialyzing liquid and the lines constitutingthe intake branch carrying the blood back to the patient consist ofseparate parts that are connected and cooperate during operation afterbeing suitably assembled.

[0005] There are also apparatus that are available on the market atpresent, designed in particular for intensive treatment of kidneyfailure, which are advantageously equipped with integrated modulescomprising a support structure, a dialyzing filter engaged to thesupport structure by means of a suitable support projecting from saidstructure, as well as a hydraulic circuit comprising the tubes that arenecessary to define the blood suction and return lines leading to thepatient, the possible lines for the infusion of anticoagulant orsubstitution liquids, the intake line for the dialysis liquid and thedischarge line for the liquid coming out of the second chamber of thedialyser.

[0006] The integrated modules described above enable an easy andimmediate association of the lines to the treatment apparatus and do notrequire any connection between the treatment unit, such as for instancea dialysis filter, and the various tubes or lines designed to conveyblood and other fluids. Moreover, said integrated modules enable theremoval both of the tubes conveying the blood and of the tubes conveyingother fluids at the end of the treatment. In other words, thanks to asimple loading and connecting operation of the terminals and of thefluid conveyance lines to the corresponding sources such as bags orothers, the user can install a dialysis apparatus. Analogously, once thetreatment step is over, by simply disconnecting and disassembling theintegrated module from the blood treatment apparatus in few operations,the operator can completely eliminate both extracorporeal circuit andthe blood treatment unit, as well as the tubes for the circulation ofpossible infusion liquids and of the dialysis liquid. The easyinstallation of said modules ensures an efficiency and a speed that arecertainly advantageous for intensive treatments where the personnel, whomight not be conversant with the use of blood treatment apparatuss, canthus operate rapidly and with a high reliability.

[0007] In particular, it is known about integrated modules forextracorporeal blood treatment in which a quadrangular plate, thanks tothe use of an auxiliary engagement structure, centrally carries theblood treatment filter and also supports on each of its sides four tubelengths of corresponding lines of the fluid distribution circuitry.

[0008] In particular, each of the four sides has two connectors to whicha respective tube length, basically semicircular, is secured; eachlength can be engaged by a respective peristaltic pump.

[0009] The four ring-shaped tube lengths extend away from the four sidesand all have the same shape and size.

[0010] In particular, the part of the module consisting of the supportplate and of the U-shaped tube lengths is symmetrical with respect totwo orthogonal axes.

[0011] The arrangement referred to above, though being widely used todayin integrated modules designed for intensive therapy apparatus, hasproved to be susceptible of several improvements.

[0012] First of all, it should be noted that the particular relativearrangement of the various U-shaped tube lengths and, therefore, of therespective pumps supported by the apparatus do not allow to optimize thelengths of the various portions of tubes in which blood, dialysisfluids, waste fluids, etc.

[0013] Furthermore, it is not possible to use pumps with larger size(which would thus involve U-shaped tube lengths with larger size) in anyof the lines without prejudicing the compactness and the overalldimensions of the integrated module.

[0014] Eventually, it should be noted that the module at the state ofthe art is necessarily designed for a maximum of four peristaltic pumpsfor conveying the respective fluids, since other infusion lines beyondthose that are already provided cannot be installed.

SUMMARY OF THE INVENTION

[0015] The present invention therefore aims at solving basically thedrawbacks and operating limitations referred to above.

[0016] A first aim of the invention is to carry out an integrated modulein which the arrangement of the various tube lengths allows a highcompactness of said module as well as an optimal distribution of thelengths of the various lines of the hydraulic circuit.

[0017] A further aim of the invention is to enable the presence of atleast a blood line in which the biological fluid can be conveyed bypumps with larger radial size without damaging the compactness of saidintegrated module.

[0018] Finally, an auxiliary aim of the invention is to carry out anintegrated module that can protect the various U-shaped tube lengths onwhich the peristaltic pumps act, thus protecting also the latter whilethe apparatus is working.

[0019] These and other aims, which shall be evident in the course of thepresent description, are basically achieved by an integrated module andby an apparatus as described in the appended claims.

[0020] Further characteristics and advantages will be clearer from thedetailed description of a preferred though not exclusive embodiment of asupport element, of an integrated module and of a correspondingapparatus for extracorporeal blood treatment according to the presentinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] This description will be given below with reference to theappended drawings, which are provided as a mere guidance and aretherefore not limiting, in which:

[0022]FIG. 1 shows a schematic view of a hydraulic circuit carried outby an apparatus and a module according to the present invention;

[0023]FIG. 2 shows a view from above of a support element according tothe present invention;

[0024]FIG. 3 shows a section of the module of FIG. 2 according to lineIII-III;

[0025]FIG. 4 shows a further section of the element of FIG. 2 accordingto line IV-IV;

[0026]FIG. 5 shows again a section according to line V-V of FIG. 2;

[0027]FIG. 6 shows a section according to line VI-VI of the supportelement of FIG. 2;

[0028]FIG. 7 shows a perspective view from a first side of the supportelement of FIG. 2;

[0029]FIG. 7a shows an enlarged detail of the element of FIG. 7;

[0030]FIG. 8 shows a perspective view from the opposite side of thesupport element of FIG. 7;

[0031]FIG. 8a shows an enlarged detail of the element of FIG. 8;

[0032]FIG. 9 shows a perspective view of an integrated module accordingto the present invention;

[0033]FIG. 9a shows an enlarged detail of the module of FIG. 9;

[0034]FIG. 10 shows a perspective view from the opposite side of themodule of FIG. 9;

[0035]FIG. 10a shows an enlarged detail of the module of FIG. 10;

[0036]FIG. 11 shows the integrated module of FIG. 10 to which a bloodtreatment unit can be associated;

[0037]FIG. 12 shows a section of a connector of the support element andof a counter-connector of the blood treatment unit;

[0038]FIG. 13 shows a further section of a connector according to thepresent invention;

[0039]FIG. 14 shows a schematic view of the integrated module that canbe associated to the apparatus, equipped with the hydraulic circuitry;

[0040]FIG. 15 shows an apparatus according to the present invention towhich an integrated module can be associated; and

[0041]FIG. 16 shows a front view of the apparatus of FIG. 15 with anintegrated module without the hydraulic circuitry thereto associated.

DETAILED DESCRIPTION

[0042] With reference to the figures mentioned above the numeral 4globally refers to a support element according to the present invention.

[0043] Conversely, the numeral 1 refers to an integrated module(combination of a support element 4, a distribution circuitry 15 and ablood treatment unit 5) that can be used together with extracorporealblood treatment apparatus 2 according to the present invention.

[0044] As can be inferred from the appended Table 1, the globalhydraulic circuit carried out thanks to the cooperation between theintegrated module and the apparatus consists of a blood line or circuit44, which takes blood from a patient, for instance by means of acatheter introduced into a vein or artery of said patient, and throughat least an intake branch or inlet line 46 carries said blood, forinstance continuously, to a filtration unit 5.

[0045] Then the blood passes through a primary chamber of saidfiltration unit 5 and through an outlet line 47 the treated blood iscarried back to the patient.

[0046] The connection with an auxiliary pre-infusion line 50 is providedimmediately downstream from the blood collecting zone on the inlet line46.

[0047] In particular, the apparatus is equipped with at least asecondary fluid container or bag 87 for supplying the pre-infusion line50; by using corresponding means for conveying fluid, in the exampleshown comprising an auxiliary pre-infusion pump 3e, for instance aperistaltic pump, it is possible to control the fluid flow within saidline by introducing said fluid directly into the blood by means of adirect connection to the inlet line 46.

[0048] Generally, the secondary fluid container 87 can house a suitablebiological fluid for a pre-infusion, however said bag 87 can alsocontain an anticoagulant, generally having such a topical nature as toensure a particular working of the apparatus as shall be explained belowin further detail.

[0049] After defining a direction of blood circulation 88 from the inletline 46 towards the filtration unit and from the latter through theoutlet line 47 towards the patient, a known blood pressure sensor 89,which shall not be described in further detail, is placed immediatelydownstream from the auxiliary pre-infusion line 50.

[0050] The blood circuit 44 therefore comprises means for conveyingfluid, i.e. in this particular case at least a blood pump 3 a forcontrolling and managing the suitable blood flow in the circuit.

[0051] Also the blood pump 3 a is generally a peristaltic pump.

[0052] Following the direction of blood circulation 88, there is then adevice 90 for administering an anticoagulant, for instance a syringecontaining suitable doses of heparin.

[0053] The blood then passes through another pressure sensor 91controlling the correct flow within the blood circuit.

[0054] After passing through a main chamber of the filtration unit 5,where the suitable exchanges of substances, molecules and fluids occurby means of a semipermeable membrane, the treated blood enters theoutlet line 47 first passing through a gas separating device (generallyair) 52 commonly known as “bubble trap”, designed so as to ensure theremoval of substances or air bubbles present in the blood or introducedinto the blood during treatment.

[0055] The treated blood getting out of the separating device 52 thenpasses through an air bubble sensor 92 verifying the absence of saiddangerous formations within the treated blood that has to bere-introduced in the patient's blood circulation.

[0056] Immediately downstream from the bubble sensor 92 there is anelement 93 which, in case of alarm, can block the blood flow towards thepatient.

[0057] In particular, should the bubble sensor 92 detect the presence ofanomalies in the blood flow, the apparatus through the element 93 (be ita tap, a clamp or similar) would be able to block immediately thepassage of blood so as to avoid any consequence to the patient.

[0058] Downstream from said element 93 the treated blood is then carriedback to the patient undergoing therapy.

[0059] The extracorporeal blood treatment apparatus shown above is thenequipped with a fluid circuit 94, which is also provided with at leastan inlet line 48 leading into the filtration unit 5 and with an outletline 45 b from the filtration unit.

[0060] At least a primary fluid container 95 is designed to supply theinlet line 48 of the fluid circuit 94 (generally the primary fluidcontainer 95 shall consist of a bag containing a suitable dialyzingliquid).

[0061] The inlet line 48 then comprises means for conveying fluid suchas a least a pump 3 c (in the embodiment shown a peristaltic pump) forcontrolling the flow of liquid from the bag 95 and for defining adirection of circulation 96.

[0062] Downstream from the pump 3 c in the direction of circulation 96there is a branching 85 splitting the fluid circuit 94 up into an intakebranch 76 and into an infusion branch 77.

[0063] In particular, the infusion branch 77 is connected to the outletline 47 of the blood circuit 44.

[0064] In other words, by means of said infusion branch 77 it ispossible to obtain a post-infusion directly in the blood line using thecontent of the primary fluid container 95.

[0065] Conversely, the intake branch 76 conveys the fluid directly tothe filtration unit and in particular to a secondary chamber of saidunit.

[0066] The fluid circuit 94 is further equipped with selecting means 97for determining the percentages of fluid flow within the infusion branch77 and the intake branch 76.

[0067] Generally said selecting means 97, usually placed near thebranching 85, can be positioned at least between a first operatingcondition in which they allow the passage of fluid in the intake branch76 and block the passage in the infusion branch 77, and a secondoperating condition in which they allow the passage of fluid in theinfusion branch 77 and block the passage in the intake branch 76.

[0068] In other words, said selecting means 97 can consist of a valveelement operating on the fluid circuit 94 by alternatively blocking thepassage of fluid in either branch.

[0069] It is also evident that it might be provided for suitableselectors, which are able to establish a priori the amount of liquidthat has to pass through both branches simultaneously.

[0070] It will also be possible to vary the percentages of fluid ineither branch as a function of time and of the preestablished therapies.

[0071] The dialyzing liquid through the intake branch 76 gets into asecondary chamber of the filtration unit 5.

[0072] In particular, the primary chamber through which the blood flowpasses is separated from the secondary chamber through which thedialyzing liquid passes by means of a semipermeable membrane ensuringthe suitable passage of the dangerous substances/molecules and of fluidfrom the blood towards the dialyzing liquid mainly by means ofconvection and diffusion processes, and also ensuring through the sameprinciples the passage of substances/molecules from the dialyzing liquidtowards the blood.

[0073] The dialysis fluid then gets into the outlet line 45 and passesthrough a suitable pressure sensor 98 whose function is to control theworking of said line.

[0074] Then there are means for conveying fluid, for instance a suctionpump 3 b controlling the flow in the outlet line 45 within the fluidcircuit 94.

[0075] Also said pump will generally be a peristaltic pump.

[0076] The fluid to be eliminated then passes through a blood detectorand is conveyed into a collection container or bag 99.

[0077] Further analyzing the peculiar circuit of the apparatus accordingto the invention, note the presence of at least another infusion line 51acting on the outlet line 47 of the blood circuit 44.

[0078] In particular, the infusion fluid is taken from at least anauxiliary container 200 and is sent directly to the outlet line 47 ofthe blood circuit 44 through means for conveying fluid, generally aninfusion pump 3 d controlling its flow (in the example a peristalticpump).

[0079] In particular and as can be observed in the appended figure, theinfusion liquid can be introduced directly into the gas separatingdevice 52.

[0080] As can also be inferred, the infusion branch 77 of the fluidcircuit 94 and the infusion line 51 are equipped with a common endlength 201 letting into the blood circuit 44.

[0081] Said intake end length 201 is placed downstream from the infusionpump 3 d with respect to a direction of infusion 202 and carries thefluid directly into the bubble trap device 52.

[0082] Further referring to the diagram in FIG. 1, note the presencewithin the infusion line 51 of at least a pre-infusion branch 79connected to the inlet line 46 of the blood circuit 44.

[0083] In further detail, downstream from the infusion pump 3 d withrespect to the direction of infusion 202, there is a branching 86splitting the infusion line 51 up into pre-infusion branch 79 andpost-infusion branch 80.

[0084] The pre-infusion branch 79, in particular, carries the fluidtaken from the bag 200 on the inlet line 46 of the blood circuitdownstream from the blood pump 3 a with respect to the direction ofcirculation 88.

[0085] Conversely, the post-infusion branch 80 is connected directly tothe common end length 201.

[0086] The infusion line 51 further comprises selecting means 203 fordetermining the percentage of liquid flow to be sent to thepost-infusion branch 80 and to the pre-infusion branch 79.

[0087] The selecting means 203 placed near the branching 86 can bepositioned between at least a first operating condition in which theyallow the passage of fluid in the pre-infusion branch 79 and block thepassage in the post-infusion branch 80, and at least a second operatingcondition in which they allow the passage of fluid in the post-infusionbranch 80 and block the passage in the pre-infusion branch 79.

[0088] Obviously, as in the case of the selecting means 97 present onthe fluid circuit 94, also the other selecting means 203 will be able todetermine the percentage of fluid that has to pass in each of the twobranches and to possibly vary it in time in accordance with the plannedtherapies. Moreover, the selecting means 97 and the other selectingmeans 203 will generally though not necessarily be of the same nature.

[0089] The apparatus is then equipped with means 204 for determining atleast the weight of the primary fluid container 95 and/or of theauxiliary fluid container 200 and/or of the secondary fluid container 87and/or of the collection container 99.

[0090] In particular, said means 204 comprise weight sensors, forinstance respective scales 205, 206, 207, 208 (at least an independentone for each fluid bag associated to the apparatus).

[0091] In particular, there will be at least 4 of said scales, each pairbeing independent from the other and measuring the respective weight ofa bag.

[0092] It should then be pointed out that there is a processing unit orCPU 209 acting on the blood circuit 44 and in particular on the pressuresensor 89, on the blood pump 3 a, on the device 90 for heparin infusion,on the other pressure sensor 91, and on the device for detecting thepresence of air bubbles 92 and on its respective closing element 93.

[0093] Said CPU 209 has also to control the fluid circuit 94 and, inparticular, shall be input with the data detected by the scales 205 andconcerning the weight of the bag 95 and shall act on the pump 3 c, onthe selecting means 97, on the pressure sensor 98, then on the suctionpump 3 b and shall eventually receive the data detected by the scales208 whose function is to determine the weight of the collectioncontainer 99.

[0094] The CPU 209 shall also act on the infusion line 51 checking theweight of the auxiliary container 200 (checked by the scales 206) andwill be able to control both the infusion pump 3 d and the otherselecting means 203.

[0095] Eventually, the CPU 209 shall also act on the auxiliarypre-infusion line 50 detecting the weight of the secondary fluidcontainer 87 by means of the scales 207 and suitably controlling thepump 3 e according to the treatments to be carried out.

[0096] Reminding that the above description has been made with the solepurpose of describing the whole of the hydraulic circuit of theextracorporeal blood treatment apparatus, here is a short description ofthe working of the device.

[0097] Once the whole hydraulic circuit and the filtering unit 5 havebeen correctly associated to the apparatus so that the variousperistaltic pumps engage the respective lengths of tubes and that allthe sensors have been suitably positioned, and the various bagscontaining the various fluids have been associated to the correspondingliquid intake/suction lines, and the blood circuit has been connected toa patient's artery/vein, the initial circulation of blood within itscircuit is enabled.

[0098] Therefore, according to the kind of therapy that has been set,the extracorporeal blood treatment apparatus is automatically startedand controlled by the processing unit 209.

[0099] If the patient undergoes an ultrafiltration treatment, beyond theblood circuit the suction pump 3 b connected to the outlet line of thefluid circuit 94 is started, so as to take by convection a fluid excessin the patient (beyond the dangerous substances/molecules).

[0100] Conversely, if the therapy that has been set comprises ahaemofiltration treatment, beyond the blood circuit and the suction pump3 b for taking fluids by convection also the pump 3 c on the inlet lineof the fluid circuit 94 is started and the selecting means 97 placed soas to enable a post-infusion.

[0101] Also the infusion line 51 shall be used so as to enable a furtheraddition of liquids to the post-infusion or to enable a suitablepre-infusion.

[0102] Conversely, if the treatment involves haemodialysis, the pumps 3c and 3 b of the fluid circuit 94 shall be started and the selectingmeans 97 shall be positioned so as to ensure the passage of thedialyzing liquid only towards the filtration unit 5 so as to takesubstances and/or molecules and/or liquids by diffusion and possibly byconvection if the transmembrane pressure through the filtration unit isother than zero.

[0103] Eventually, if a haemodiafiltration treatment has to be carriedout, beyond the blood circuit the fluid circuit and therefore the pumps3 c and 3 b shall be started, so as to ensure a circulation of theliquid within the filtration unit 5 and also the pump 3 d of theinfusion line 51 shall be started so as to ensure a pre- orpost-infusion.

[0104] Obviously, it will be possible to set up different therapiescomprising one or more of the treatments referred to above.

[0105] In all the treatments described above, possibly except theultrafiltration treatment, it will be possible to use the auxiliarypre-infusion line for introducing an anticoagulant and/or a suitableinfusion liquid into the blood.

[0106] Obviously, the anticoagulant can also be administered by means ofthe suitable device 90 designed for the introduction of heparin intoblood.

[0107] Concerning this it should be pointed out that the apparatusaccording to the invention is designed to receive various kinds ofsyringes according to the amount of anticoagulant to be administered.

[0108] Obviously, it is the control unit 209 that, being connected tothe various devices, sensors, pumps and being input with the weight datafrom the various scales, is able—once it is set—to control and automatethe whole working of the apparatus.

[0109] In further detail, it is possible to set the flows of the variouspumps present on the apparatus in accordance with the therapy ortherapies to be started.

[0110] Obviously, the suitable setting of said flows results in anamount of fluid taken from the patient (weight loss), which willgenerally be given by the difference between the weight of the liquidthat has been collected in the bag 99 and of the liquid circulated inthe circuit through the primary fluid container 95, the auxiliary fluidcontainer 200 and the secondary fluid container 87.

[0111] In particular, in accordance with the data received by thecontrol unit coming from the various scales (and the theoretical flowrates fixed on each pump of therapy/treatment carried out) the controlunit 209 shall control the means for circulating fluid in the variouslines by suitably varying the thrust exerted by the various pumps 3 a, 3b, 3 c, 3 d, 3 e.

[0112] In particular, the signals coming from the scales referred toabove 205, 206, 207, 208 are used by the control unit 209 fordetermining the weight of the particular fluid introduced into the lineor collected.

[0113] In order to determine the amount of fluid released or collectedin a particular bag or container the control unit 209 compares atregular intervals (the greater the flows the smaller the intervals) theactual weight of the container with the desired weight (which is adirect function of the desired flow for each pump and of the timeinterval between each control step ΔW=Q Δt).

[0114] The desired weight can be calculated as a function of therequired flow (stored in a suitable storage unit of the computer) and ofthe time elapsed from the beginning of the treatment.

[0115] If the actual weight and the desired weight differ from eachother, the control unit acts on the corresponding pump so as to reduce,and possibly cancel, said difference. In other words, during each cyclenot an absolute weight variation, but only the variation in the timeinterval is taken into consideration to correct the latter.

[0116] The control unit takes into consideration variations in thedifference starting from the last comparison, so as to avoidoscillations of the actual flow around the desired flow.

[0117] After the above description of the hydraulic circuit and of thepossible working of the apparatus according to the inventionincorporating said circuit, here is shown a detailed structure of thesupport element 4 according to the invention.

[0118] The support element as shown in the FIGS. 2 to 8 a generallyconsists of a main body 6 and of a support structure 64 associated tosaid main body 6 and placed laterally with respect to the latter.

[0119] The main body 6 has a front wall 25 which is generally, thoughnot necessarily, plane; then there is at least a peripheral wall 32projecting away from the front wall 25 so as to define with the latter ahousing compartment 33 designed to receive at least a portion of a fluiddistribution circuit 15 to be associated to said support element.

[0120] As can be seen from FIG. 2, the front wall 25 is delimited by agiven number of sides 53, 54, 55 and 56, and the peripheral wall 32projects away from each of said sides.

[0121] It should be noted that the sides referred to above are basicallyrectilinear and, generally, at least first sides 55, 56 and at leastsecond sides 53, 54 can be identified, which are basically parallel andfacing each other.

[0122] In other words, in a view from above the support element 4 has anapproximately quadrangular shape and its front wall 25 is delimited byfirst opposite longer sides 55, 56 with a basically rectilineardevelopment and having each two curved portions 55 a, 55 b; 56 a, 56 bwhose cavities face their respective opposite side.

[0123] In further detail each of said curved portions 55 a, 55 b; 56 a,56 b can be defined by an arc of circle.

[0124] Then there are second opposite shorter sides 53, 54, whosedevelopment is again basically rectilinear; at least one of said secondsides 53, 54 has a curved portion 53 a placed between two rectilinearlengths 53 b, 53 c, which has in its turn a cavity facing the oppositeside.

[0125] Here again the curved portion 53 a can be defined by an arc ofcircle.

[0126] As can be further noted by simply observing FIG. 2, the arc ofcircle defining the curved portion 53 a has a greater radius ofcurvature than the curved portions 55 a, 55 b, 56 a, 56 b defined on thefirst opposite longer sides 55, 56, as shall be better explained later.

[0127] Examining now the peripheral wall 32 (see FIGS. 7 and 8), it canbe noted that it has at least a portion projecting away from each of thesides of the support element 4.

[0128] Generally, there will be at least one portion projecting from thefirst opposite sides 55, 56, and one projecting away from each of thesecond opposite sides 53, 54.

[0129] It is also evident that the peripheral wall 32 can also bediscontinuous, i.e. it can have cavities or interruptions provided thatit globally enables to define the aforesaid housing compartment 33.

[0130] The embodiment shown in FIGS. 7 and 8 is characterized in thatthe peripheral wall 32 projects away from all the sides of the frontwall 25 and defines a basically continuous surface delimiting thehousing compartment 33.

[0131] In other words, the housing compartment 33 has an access opening57 without any kind of closing wall, which access opening is designed toface—when the support element 4 is being used—the extracorporeal bloodtreatment apparatus 2.

[0132] Moreover, from FIGS. 3, 4, 5 it can be inferred how sectionsaccording to a plane transversal with respect to the front surface, andin particular sections according to planes orthogonal to said frontsurface 25, show that the main body has a substantially C-shapedprofile.

[0133] The peripheral wall 32 defines the two end lengths of said C,whereas the front wall 25 defines the intervening elongated length.

[0134] It should be noted how the front wall 25 and the peripheral wall32 define a main body 6 having a box-shaped structure basically closedon five out of its six faces.

[0135] Said arrangement results in that, however sectioning the supportelement 4 according to two planes orthogonal one to the other andtransversal to the front surface 25, the main body 6 will have C-shapedsections that are also orthogonal one to the other.

[0136] See in particular for instance the sections of FIGS. 3 and 4.

[0137] In still other words, the support element 4 comprises a frontwall 25 which is able to connect opposite peripheral walls projecting ina basically perpendicular direction from said front wall 25.

[0138] As shown in FIGS. 2, 7 and 8, the front wall 25 has a givennumber of through openings 58 putting into communication the housingcompartment 33 with the outside environment while the support element isbeing used.

[0139] Referring in particular to the figures described above, it can benoted that there is at least an opening 58 on each of the curvedportions 53 a, 55 a, 55 b, 56 a and 56 b and that said openings aredefined by concentric round holes placed on the same axis as therespective arcs of circle defining the curved portions.

[0140] As far as the materials used are concerned, it should only bepointed out that the main body will be made of a stiff material, plasticfor instance, which can protect the various tube lengths and/or elementstherein contained.

[0141] It is also possible to carry out the whole support element oronly a part of it with a material that is also transparent so as toobtain a visual access to the housing compartment 33.

[0142] Going into deeper structural details and referring in particularto FIG. 7, it can be noted that there are several engagement connectorsfastened to the respective sides of the box-shaped body.

[0143] In particular, there are at least a first and a second engagementconnector 59 a, 59 a placed laterally with respect to the curvilinearlength 53 of one of said second sides 53.

[0144] Said connectors shall be secured and generally carried out as onepiece with said rectilinear lengths 53 b and 53 c.

[0145] There are also pairs of engagement connectors 60 a, 60 b, 61 a,61 b, 62 a, 62 b, 63 a, 63 b respectively engaged near each of thecurved portions 55 a, 55 b, 56 a, 56 b of the first longer sides 55, 56.

[0146] In other words, there will be two of said connectors placedexactly on opposite ends of each of the curved portions.

[0147] As in the case of the previous connectors, also the engagementconnectors 60 a, 60 b, 61 a, 61 b, 62 a, 62 b, 63 a, 63 b are carriedout as one piece with the main body 6.

[0148] Furthermore, all the aforesaid connectors are fastened to theperipheral wall 32, for instance on a free edge of said peripheral wall.

[0149] As can be seen in the section of FIG. 5, each engagementconnector defines a gap leading towards the housing compartment 33.

[0150] Referring now to FIGS. 7a and 8 a, it can be noted how thesupport structure 64 associated to the main body 6 is positionedlaterally with respect to the latter.

[0151] Also the support structure 64 is stiffly secured to the main bodyand will generally be carried out as one piece with the latter.

[0152] It should be pointed out that the support structure 64 is engagedto the main body 6 on one of the first longer sides 55, 56 and, infurther detail, on the curved portions 55 a, 55 b of said fist longerside 55.

[0153] The support structure 64 is equipped with a positioning fin 65(see again FIGS. 7a, 8 a and the section of FIG. 6), which has a givennumber of main seats 66 a, 66 b, 66 c, 66 d, 66 e suitably placed sothat respective tubes of the fluid distribution circuit 15 associated tothe support element 4 can be engaged therein.

[0154] Referring to the relative position of the various components ofthe support structure 64, it can be noted how at least two, andgenerally three of said main seats 66 a, 66 c, 66 d are placed on theirrespective engagement connector 60 a, 60 b, 61 a located near the curvedportions 55 a, 55 b of one of the first longer sides 55.

[0155] In other words, the three main seats 66 a, 66 c, 66 d and theirrespective connectors 60 a, 60 b, 61 a are positioned so as to receiveparallel tube lengths (see to this end FIGS. 9 and 9a).

[0156] Going back to FIG. 6 and to FIGS. 7a and 8 a, it can be noted howthe positioning fin 65 comprises two further main seats 66 b and 66 eand how also the support structure 64 is equipped with two auxiliaryportions 67 and 68, each of them being provided with a respectiveauxiliary seat 67 a, 68 a so that the latter can cooperate with oneanother thus enabling the positioning of tube lengths parallel one tothe other and generally parallel to those present on the three mainseats and on the three engagement connectors referred to above (seeagain FIGS. 9 and 9a).

[0157] The support structure 64 then comprises at least a first coveringwall 69 lying on a plane parallel to the plane of the front wall 25 soas to cover at least two parallel tube lengths in operating conditionsin which the support element is engaged to the apparatus.

[0158] Compare to this end FIGS. 9 and 16.

[0159] In a wholly specular way the support structure 64 comprises atleast a second covering wall 70 lying again on a plane parallel to theplane of the front wall 25 so as to cover at least two further paralleltube lengths when the support element is again in operating conditions.

[0160] Referring to FIG. 8 it should then be pointed out that thesupport element 64 has a smaller height than—or at the most the sameheight as—the peripheral wall 32 of the main body.

[0161] This means that the support structure 64 has been designed so asnot to increase the height of the whole support element.

[0162] Referring now to FIG. 7, further note at least one and ingenerally two positioning projections 72 and 73 associated to the mainbody 6 and designed to enable the correct positioning of a tube lengthto be associated to the support element as shall be better explainedlater (see anyway FIGS. 9 and 14).

[0163] Said first and second positioning projections 72, 73 are placedinside the housing compartment 33 and are generally associated (or alsocarried out as one piece) to the front wall 25.

[0164] It should then be noted that the support element 4 comprises amain body 6 having at least a first and a second connector 7 and 8,spaced away from each other, in which corresponding counter-connectors 9and 10 of the treatment unit 5 (see FIG. 11) are engaged.

[0165] The blood treatment unit 5 can for instance be a plasma filter, ahaemodialysis filter, a haemofiltration filter, a haemodiafiltrationfilter or another type of unit.

[0166] The first and second connector 7 and 8 are directly engaged tothe main body 6; in the examples shown said connectors are made of stiffplastic material and as one piece with the main body.

[0167] The support element 4 has a third connector 11 spaced away fromthe connectors 7 and 8 and engaged directly to the main body 6; in theexamples shown also the third connector is made of stiff plasticmaterial and as one piece with the main body; said three connectorsdefine pairs of connectors having a differentiated central axis one withrespect to the other for the engagement of corresponding pairs ofcounter-connectors associated to different blood treatment units thatcan be mounted onto the support element. Thus, one main body 6 can beused to carry out integrated modules with different features, thanks tothe possibility of engaging treatment units 5 not only with differentmembranes but also with different global size and therefore withdifferent central axis of the corresponding counter-connectors. Each ofthe connectors 7, 8, 11 referred to is a stiff support and defines afluid passage having a first end portion 12, designed to be put intofluid communication with a corresponding channel 13 present in therespective counter-connector 9, 10 housed in the treatment unit 5 (seealso the sections of FIGS. 12 and 13); each connector 7, 8, 11 also hasa second end portion 14, designed to be put into fluid communicationwith a fluid distribution circuit 15 to be associated to the main body6. Going into further structural detail, each of said connectors 7, 8,11 comprises a tubular channel 16 defining said first portion, a sealingcollar 17 placed radially outside the tubular channel, and a connectionwall 18 developing without interruptions between an outer side surface19 of the tubular channel and an inner side surface 20 of said collar.In practice, the outer side surface of the tubular channel, the innerside surface of the sealing collar and the connection wall define aring-shaped engagement seat 21, whose bottom is delimited by theconnection wall, shaped so that a corresponding counter-connector of thetreatment unit can be engaged therein. The tubular channel 16 isarranged coaxially with respect to the sealing collar 17, and both turnaround a common symmetry axis. The ring-shaped seat 21 has an increasingradial size getting away from the bottom wall and comprises a first zone22 near the bottom, having a constant radial size, a second zone 23,distal with respect to the bottom and with a constant radial sizegreater than the radial size of the first zone, and a third zone 24between the first and the second zone, having a progressively increasingsize getting away from the bottom wall 18. The tubular channel and thesealing collar of each connector 7, 8, 11 project parallel one to theother from the main body 6, so as to define one direction of couplingwith the corresponding counter-connectors of a treatment unit 5. In theexamples of embodiment shown the various connectors have a symmetry axisthat is basically orthogonal with respect to a front surface 25 of thesupport element 4.

[0168] The support element shown also comprises a fourth connector 26spaced away from said first, second and third connector; the fourthconnector is also connected directly to the support element. In theexample shown the fourth connectors is made of stiff plastic materialand as one piece with the main body 6 and defines with at least one ofthe other connectors a further pair of counter-connectors associated toa blood treatment unit to be mounted onto the support element. Thefourth connector comprises a central cylindrical positioning body 27, asealing collar 28 placed radially outside the cylindrical body, and aconnection or bottom wall 29 developing without interruptions between anouter side surface 30 of the cylindrical body and an inner side surface31 of said collar. In practice, said fourth connector defines anengagement and flow-closing body for a counter-connector of thetreatment unit 5. As shown in FIGS. 11, 12 and 13, the variousconnectors are made of stiff material so as to define a mechanicalsupport of the treatment unit and, if needed, so as to define a passageor a blocking member for the fluid getting through thecounter-connectors 9, 10. The four connectors that are present in thesupport element are aligned one with respect to the other and arrangedon one side of said main body. More to the point, the main body of theelement shown defines the aforesaid housing compartment 33, which canhouse at least a portion of the fluid distribution circuit 15 designedto be associated to the support element 4. The housing seat has an openside 57 ensuring a suitable fitting and positioning of the integratedmodule 1 onto the apparatus 2, as shall be disclosed later in furtherdetail. The support element then has an auxiliary structure 35 extendinglaterally and outside with respect to the operating seat from a basezone 36 of the peripheral wall 32. The four connectors come out from theauxiliary structure the first, second and fourth 7, 8, 26 are placed onebeside the other and are arranged on a first end zone 37 of theauxiliary structure, whereas the third connector 11 is placed on asecond end zone 38 placed opposite the first one.

[0169] A support element according to the invention can be suitably usedfor carrying out an integrated module, such as for instance the oneshown in FIGS. 9-11, in which the support element of FIGS. 2-8 is usedby way of example. As can be seen, the treatment unit 5 is fastened tothe support element 4 on at least the pair of connectors; the treatmentunit comprises a housing body 40, at least a semipermeable membrane 41(for instance with parallel hollow fibers or with plates) operatinginside the housing body and defining a first chamber and a secondchamber; a first and a second counter-connector are associated to thehousing body and secured to their respective connectors housed by themain body 6 (see for instance FIG. 11).

[0170] The first and second counter-connector 9, 10 have a tubular shapeand are put into fluid communication with the second chamber of thetreatment unit and with respective end portions 12 of said connectors.The treatment unit then has an access port 42 leading to the firstchamber, and at least an exit port 43 from said first chamber, for theconnection with an extracorporeal circulation line 44 for blood oranother physiological fluid.

[0171] A fluid distribution circuit 15 is engaged to the support element4 and cooperates with the treatment unit 5.

[0172] In further detail said circuit comprises the aforesaid blood line44, which is fastened to the support element 4 on one of the secondsides 53, 54 and has the curved portion 53 a.

[0173] The blood line 44 is secured to the support element so as todefine at least a tube length basically arranged as a U 44 a withrespect to said support element.

[0174] Said arrangement is related to the fact of enabling thecooperation between said tube length 44 a and a respective pump 3 awhile assembling the integrated module onto the apparatus 2.

[0175] As can then be inferred from the appended figures, the U-shapedtube length 44 extends inside with respect to the peripheral wall 32 ofthe support element 4.

[0176] The positioning projections 72, 73 previously described act onthe U-shaped tube length 44 a so as to keep its correct position.

[0177] As can be inferred from FIGS. 1 and 9, the length 44 a of theblood line 44 secured to the support element is defined by the intakebranch 46.

[0178] The distribution circuit 15 then has the aforesaid inlet line 48supplying fresh dialysis liquid.

[0179] Said line is fastened to the support element on one of the firstlonger opposite sides 55, 56, as can be seen in FIGS. 9, 9a, 10 and 10a.

[0180] Also the inlet line 48 is secured to the support element so as todefine at least a tube length basically arranged as a U 48 a withrespect to said support element.

[0181] Also the tube length 48 is designed to cooperate with arespective pump 3 c and is placed inside with respect to the peripheralwall 32 of the support element.

[0182] Referring to FIG. 9a it can be noted how the inlet line 48 isfastened to the main body 6 on the support structure 64, and how atleast an inlet length 74 of the inlet line 48 is engaged into a mainseat 66 c of the positioning fin 65, as well as to the respectiveengagement connector 60 b.

[0183] Analogously, at least an outlet length 75 of the inlet line isengaged into a main seat 66 a of the positioning fin 65 and to therespective engagement connector 60 a.

[0184] When engaged, the respective connectors and inlet and outletlengths 74 and 75 are placed in a rectilinear arrangement and areparallel one to the other (see FIG. 9a).

[0185] As can further be seen (see in particular FIG. 10a), the outletlength 5 has a branching 85 splitting up into intake branch 76 conveyingthe fluid to the blood treatment unit 5, and into infusion branch 77conveying the fluid into the blood line 44.

[0186] Said branching 85 is defined on the engagement connector 60 ahaving a T shape with an inlet and two outlets.

[0187] Also the infusion branch 77 is secured to a main seat 66 b and toan auxiliary seat 77 a.

[0188] The infusion branch 77 and the intake branch 76, when engaged tothe support structure 64, are placed in a rectilinear arrangement andare parallel one to the other.

[0189] The fluid distribution circuitry 15 then comprises at least theinfusion line 51, which is also fastened on one of the first longeropposite sides 55, 56.

[0190] Said infusion line defines a tube length arranged as a U 51 awith respect to said support element 4, so as to be able to cooperate,when in use, with a respective pump 3 d.

[0191] Also the U-shaped tube length 51 a extends inside with respect tothe peripheral wall 32 of the support element.

[0192] Also the infusion line is secured on the support structure 64 andat least an outlet length 78 of the infusion line 71 is engaged into amain seat 66 d of the positioning fin 65 and to its respectiveengagement connector 61 a as shown in the appended figures.

[0193] In a wholly specular way to the intake line, the outlet length 78has a branching 86 splitting up into pre-infusion branch 79 conveyingthe fluid to an intake branch 46 of the blood line 44, and intopost-infusion branch 80 conveying the fluid to a blood return branch 47of the blood line.

[0194] Here again there is an engagement connector 61 a having a T shapeso that the branching 86 into pre-infusion branch 79 and intopost-infusion branch 80 is defined exactly by said connector 80.

[0195] The pre-infusion branch 79 is then fastened to an auxiliary seat68 a and to a further main seat 66 e of the positioning fin 65.

[0196] When engaged to the support structure, said two branches 79 and80 are placed in a rectilinear arrangement and are parallel to oneanother.

[0197] The fluid distribution circuit 15 then has the discharge line 45secured to the support element also on one of said first longer sides55, 56.

[0198] Said discharge line 55 defines at least a tube length arranged asa U 45 a with respect to the support element, which tube length is alsodesigned to cooperate with a respective pump 3 b and extending insidewith respect to the peripheral wall 32 of the support element.

[0199] The discharge line 45 is secured to the main body 6 on anopposite side with respect to the support structure 64 and therespective inlet length 81 and outlet length 82 are engaged intocorresponding engagement connectors 62 b, 62 a.

[0200] Eventually, the distribution circuit 15 has the auxiliarypre-infusion line 50.

[0201] The latter is fastened to the support element 4 on one of saidfirst longer sides 55, 56 so as to define at least a further tube lengtharranged as a U 50 a with respect to said support element.

[0202] Also the tube length 50 a is designed to cooperate, when in use,with a respective pump 3 e and extends inside with respect to theperipheral wall 32 of the support element.

[0203] In other words, the housing compartment 33 is designed to houseall U-shaped tube lengths of the various lines of the distributioncircuitry 15.

[0204] The auxiliary pre-infusion line 50 is secured to the main body onan opposite side with respect to the support structure 64 and therespective inlet length 83 and outlet length 84 are engaged toengagement connectors 63 b, 63 a.

[0205] It should then be pointed out that the particular shape of theperipheral wall 32 of the support element 4 defining the arched portionsand the peculiar position of the engagement connectors of the varioustubes result in that the length of every free U-shaped tube portion 44a, 45 a, 48 a, 50 a, 51 a is smaller than or the same as πR+2R, where Ris the radius of curvature of the tube length.

[0206] The peculiar shape of the integrated module is such that the freelengths within the housing compartment 33 are as short as possible inaccordance with the radial sizes of the respective pumps which have togenerate the flow within said tubes.

[0207] It should then be noted how the U-shaped tube length 44 a of theblood line is longer than the tube lengths 45 a, 48 a, 50 a, 51 adefined by the further fluid lines having indeed a longer radius ofcurvature.

[0208] Moreover, the tube length of the blood line can be carried out,if needed, with materials differing from those of other tubes and/or itcan have sections for the passage of fluid differing from the othertubes.

[0209] From the point of view of the geometrical position of the varioustube lengths on the support element note the following.

[0210] First of all, the support element can be ideally divided intoseveral zones comprising a first zone 274 secured to the portion of theblood line 44 which, in operating conditions of the module 1 engaged tothe apparatus 2, shall be defined by the lower zone of said module.

[0211] Therefore, there will be a second zone 275 opposite the firstzone, to which all the further fluid lines 45, 48, 50 and 51 aresecured.

[0212] Said second zone consists in its turn of at least two idealhalf-parts placed side by side 275 a, 275 b.

[0213] The tube length 45 a of the discharge line 45 and the tube length50 a of the auxiliary pre-infusion line 50 will be fastened to thesecond half-part 275 b.

[0214] Conversely, the tube length 48 of the intake line and the tubelength 51 a of the infusion line are fastened to the first half-part 275a. Said splitting into first and second zone 274, 275 and the twohalf-parts 275 a, 275 b of the second zone have been ideally shown inFIG. 9 by means of hatched lines.

[0215] As can be noted, the first and second half-part 275 a, 275 b ofthe second zone 275 are reciprocally placed side by side and generallyperfectly symmetrical to a longitudinal axis of the main body 6. Shouldthe first zone 274 be geometrically delimited, it could be defined asthe area limited by at least one of the second sides 53 (having thecurved portion and to which the blood line is secured) and by about halfthe length of the first opposite longer sides 55 and 56 near the secondside 53.

[0216] Analogously, the second zone 275 is partly delimited by one ofsaid second sides 54 which has no curve and by a portion of the firstopposite longer sides 55 and 56 near said second side 54.

[0217] The assembly process of an integrated fluid treatment modulecomprises the stage of installation of a support element 4, for instanceas shown in FIGS. 2-8, and a treatment unit 5 to be coupled to thesupport element. Then the blood treatment unit is fastened to thesupport element. Eventually, a fluid distribution circuit 15 isassociated to the support element and to the treatment unit so as tocreate the necessary lines for blood circulation, discharge, infusion ofpossible substitution liquids, dialysis. Note that the connection of thedistribution circuit to the treatment unit can be before, simultaneousto or follow the stage in which the circuitry is fastened to the supportelement. The stage in which the treatment unit is fastened to thesupport element comprises sub-stages in which a pair of connectors towhich the counter-connectors 9, 10 housed by the blood treatment unitare to be fastened are chosen, in which a given amount of glue, normallybased on a polymer resin, is placed in the ring-shaped seats 21 of eachconnector chosen, in which each counter-connector is at least partiallyfitted into its respective ring-shaped seat so as to obtain a mechanicalblocking and a liquid-sealing coupling. Note that during said fittingstage at least a portion of the glue placed in the ring-shaped seatreaches the second zone 23 of said ring-shaped seat. At the end of saidstage in which the counter-connector is fitted into its respectivering-shaped seat, the volume of glue previously placed plus the volumeof the portion of counter-connector housed within the ring-shaped seatis smaller than the total volume of said ring-shaped seat. It is thusavoided that glue migrates towards the tubular channel 16 causing itspartial or total occlusion.

[0218] The stage in which a fluid distribution circuit 15 is associatedto the support element 4 and to the treatment unit 5 comprises in itsturn the sub-stages in which an end portion of a discharge line 45 for awaste fluid is fastened fluid-sealingly with the second end portion 14of one of said connectors, and in which an end portion of an intake line48 for fresh dialysis liquid is fastened sealingly with the second endportion of another of said connectors. Said stage of association of thedistribution circuit also comprises the sealing fastening of an endportion of a blood suction branch 46 with the inlet port to the firstchamber, and an end portion of a blood return line 47 with the exit portfrom said first chamber. The fastening of the various end portionsreferred to above can take place by gluing, by forcing or by hotcoupling.

[0219] Granted the above, it should be noted that the integrated moduleaccording to the present invention is designed to be used on anextracorporeal blood treatment apparatus 2 as shown in FIGS. 15 and 16.

[0220] In particular, said apparatus 2 comprises a body 100 provided onits front surface 101 with a given number of peristaltic pumps 3 a, 3 b,3 c, 3 d, 3 e designed to cooperate with the respective U-shaped tubelengths defined on the integrated module.

[0221] As can be noted from FIG. 15, the apparatus body 11 has a guidingand positioning projection 102 protruding from the surface 101, which isexactly counter-shaped to the peripheral wall 32 of the support elementto which it should be coupled.

[0222] In other words, the guiding and positioning projection 102 has aside surface 103 which, when engaged to the integrated module, isdelimited by the peripheral wall 32.

[0223] Also the peristaltic pumps protrude from the surface 101 of theapparatus body 100 and at least a part of their side surface iscounter-shaped to the peripheral wall 32 of the support element.

[0224] In particular, it is exactly the curved portions defined by thecurved lengths of the front wall 25 which are designed to couple withthe protruding side portions of the pumps 3.

[0225] The protruding peristaltic pumps and the guiding and positioningprojection 102 define together suitable seats 104 a, 104 b, 104 c, 104 dand 104 e taking a basically semicircular or U shape and designed toreceive the corresponding U-shaped tube lengths 44 a, 45 a, 48 a, 50 a,51 a.

[0226] Analogously to what has been described for the integrated module1, also on the front wall of the apparatus a given number of zones canbe defined, and in particular two zones 174, 175 in which the first zone174 comprises the blood pump 3 a, whereas the second zone 175 comprisesthe other pumps 3 b, 3 c, 3 d and 3 e.

[0227] The second zone 175 comprises at least two half-parts placed sideby side 175 a, 175 b; the intake pump 3 c and the infusion pump 3 d areplaced in said first half-part whereas the auxiliary pre-infusion pump 3e and the suction pump 3 b are placed in the second half-part.

[0228] Here again the first and second half-part are specularlysymmetrical and placed side by side on the front wall of the apparatusand above the first zone 174.

[0229] Eventually, it should be noted that there is at least a firstmoving element 105 and a second moving element 106 that aresubstantially identical and housed directly by the apparatus body; thelatter are designed to act respectively on the infusion branch 77 and/oron the intake branch 76 (the first moving element), and on thepre-infusion branch 79 and/or on the post-infusion branch 80 (the secondmoving element 106). In particular, the selecting means 97 and 203previously described can comprise said moving elements 105, 106 designedto be controlled by the CPU 209 so as to selectively determine theblocking or passage of fluid in either branch.

[0230] In order to cooperate with said moving elements the integratedmodule is equipped with the support structure with said infusion,intake, post-infusion and pre-infusion branches, which are all parallelto one another.

[0231] The invention has important advantages.

[0232] First of all, the present invention allows to obtain anintegrated module for apparatus for extracorporeal blood treatment withan optimal arrangement of the various tube lengths of fluid lines.

[0233] The division of said module into two opposite zones allows toengage to one of the shorter sides a U-shaped tube length of a bloodcircuit with greater size than the U-shaped tube lengths of the otherfluid lines, thus enabling the use of peristaltic pumps with greatersize, which can allow higher flow rates and also, since longer tubelengths are used, less damages of the tube length on which the pumpacts.

[0234] Moreover, the particular arrangement of the intake line for freshdialysis liquid on the blood treatment element and on the post-infusionzone enables to minimize the length of the inlet portion of said intakeline, thus minimizing the amount of fresh dialysis fluid to be wasted.

[0235] The same applies also to the pre-/post-infusion lines, which isalso placed on the pre- and post-infusion zones and enables to minimizethe lengths of the various branches.

[0236] It is evident that said positioning is extremely advantageous inintensive therapy apparatuss in which all biological fluids arecontained in bags with limited volume.

[0237] Eventually, it should be pointed out that the presence of fiveperistaltic pumps on the apparatus and of corresponding U-shaped tubelengths on the integrated module enables the use of another line, inparticular of a pre-infusion line, so as to allow the introduction, forinstance, of topical anticoagulants without limiting pre- andpost-infusion possibilities.

[0238] Finally, the use of a particular support element that is open onone side and defines a basically box-shaped body enables an optimalprotection of the tube lengths of the respective peristaltic pumps whenthe unit is operating.

1. Integrated fluid treatment module comprising: a support element, afluid distribution circuitry associated to the support element andcomprising: at least a blood line, at least a portion of said blood linebeing fastened to the support element and defining at least a U-shapedtube length with respect to said support element, said tube length beingdesigned to cooperate with a respective pump; further fluid linessecured to the support element, each of them defining at least aU-shaped tube length with respect to said support element, each tubelength being designed to cooperate with a respective pump, characterizedin that the support element has a first zone to which the portion of theblood line is fastened, and at least a second zone opposite said firstzone, the other fluid lines all being fastened on said second zone. 2.Module according to claim 1, characterized in that the U-shaped tubelength of the blood line is longer than the tube lengths defined by theother fluid lines.
 3. Module according to claim 1, characterized in thatthe U-shaped tube length of the blood line has a greater radius ofcurvature than the tube lengths defined by the other fluid lines. 4.Module according to claim 1, characterized in that the fluiddistribution circuitry comprises at least a discharge line for a wastefluid.
 5. Module according to claim 4, characterized in that saiddischarge line for a waste fluid is secured to the support element anddefines at least a tube length arranged as a U with respect to saidsupport element, said U-shaped tube length being designed to cooperatewith a respective pump.
 6. Module according to claim 5, characterized inthat said second zone comprises at least two half-parts placed side byside, at least the tube length of the discharge line being fastened tothe second half-part.
 7. Module according to claim 1, characterized inthat the fluid distribution circuitry comprises at least an intake linefor fresh dialysis liquid.
 8. Module according to claim 7, characterizedin that the intake line for fresh dialysis liquid is fastened to thesupport element and defines at least a tube length arranged as a U withrespect to said support element, said tube length of the liquid intakeline being designed to cooperate, when in use, with a respective pump.9. Module according to claim 8, characterized in that said second zonecomprises at least two half-parts placed side by side, at least the tubelength of the intake line for fresh liquid being fastened to the firsthalf-part.
 10. Module according to claim 1, characterized in that itfurther comprises at least a fluid infusion line.
 11. Module accordingto claim 10, characterized in that the fluid infusion line is fastenedto the support line and defines at least a tube length arranged as a Uwith respect to said support element, said fluid infusion line beingdesigned to cooperate, when in use, with a respective pump.
 12. Moduleaccording to claim 11, characterized in that said second zone comprisesat least two half-parts placed side by side, at least the tube length ofthe infusion line being fastened to the first half-part.
 13. Moduleaccording to claim 1, characterized in that it further comprises atleast an auxiliary pre-infusion line.
 14. Module according to claim 13,characterized in that the auxiliary pre-infusion line is fastened to thesupport element and defines at least a tube length arranged as a U withrespect to said support element, said auxiliary pre-infusion line beingdesigned to cooperate with a respective pump.
 15. Module according toclaim 14, characterized in that said second zone comprises at least twohalf-parts placed side by side, at least the tube length of theauxiliary pre-infusion line being fastened to the second half-part. 16.Module according to claim 1, characterized in that the support elementcomprises a main body having a front wall and at least a peripheral wallprojecting away from said front wall, said front wall and saidperipheral wall defining a housing compartment.
 17. Module according toclaim 16, characterized in that the front wall comprises at least firstsides and second sides basically parallel and reciprocally facing. 18.Module according to claim 17, characterized in that the front wall isdelimited by first opposite longer sides with a basically rectilineardevelopment, each having two curved portions whose cavity faces itsrespective opposite side.
 19. Module according to claim 17,characterized in that the front wall is delimited by second oppositeshorter sides with a basically rectilinear development.
 20. Moduleaccording to claim 19, characterized in that at least one of said secondsides has a curved portion placed between two rectilinear lengths, thecavity of said curved portion facing the opposite side.
 21. Moduleaccording to claims 20 and 18, characterized in that the first zone ispartly delimited by at least one of said second sides having the curvedportion and by a portion of the first opposite longer sides beside saidsecond side having the curved portion.
 22. Module according to claims 20and 18, characterized in that the second zone is partly delimited by oneof said second sides without the curved portion and by a portion of thefirst opposite longer sides beside said second side without the curvedportion.
 23. Module according to claim 1, characterized in that, whenthe module is associated to an extracorporeal blood treatment apparatus,the first zone of the support element is placed below the second zone ofthe support element.
 24. Module according to claim 9, characterized inthat, when the module is associated to an extracorporeal blood treatmentapparatus, the first and second half-part of the second zone of thesupport element are placed side by side.
 25. Module according to claim20, characterized in that the tube length of the blood line is fastenedto said second side having the curved portion.
 26. Module according toclaims 7 and 18, characterized in that the tube length of the intakeline for fresh dialysis liquid is fastened to one of said first longersides.
 27. Module according to claims 4 and 18, characterized in thatthe tube length of the discharge line for a waste fluid is fastened toone of said first longer sides.
 28. Module according to claims 10 and18, characterized in that the tube length of the fluid infusion line isfastened to one of said first longer sides.
 29. Module according toclaims 13 and 18, characterized in that the tube length of the auxiliarypre-infusion line is fastened to one of said first longer sides. 30.Module according to claim 20, characterized in that one of said secondsides without the curved portion has no tube length directly fastenedthereto.
 31. Module according to claim 1, characterized in that a lengthof every U-shaped tube portion is smaller than or the same as (πR+2R),where R is the respective radius of curvature of the tube length. 32.Module according to claims 5, characterized in that the U-shaped tubelengths extend inside with respect to the peripheral wall of the supportelement.
 33. Module according to claim 16, characterized in that itfurther comprises a support structure associated to the main body andplaced laterally with respect to the latter.
 34. Module according toclaims 18 and 33, characterized in that said support structure isengaged to the main body on one of said longer sides.
 35. Moduleaccording to claim 34, characterized in that the support structure isengaged to the main body on said curved portions of one of said firstlonger sides.
 36. Module according to claim 1, characterized in that itfurther comprises at least a blood treatment unit engaged on the supportelement.
 37. Module according to claim 16, characterized in that saidsupport element comprises at least a first and at least a secondconnector associated to the main body and spaced away one from theother, said first and said second connector being designed to receive byway of engagement corresponding counter-connectors of a blood treatmentunit to be mounted onto the support element.
 38. Module according toclaims 36 and 37, characterized in that said treatment unit comprises: ahousing body; at least a semipermeable membrane operating inside thehousing body defining a first and a second chamber; a first and a secondcounter-connector associated to the housing body and fastened torespective connectors associated to the main body, at least one of saidfirst and second counter-connector being put into fluid communicationwith the second chamber of the treatment unit and with respective firstend portions of said connectors; at least an access port to said firstchamber; and at least an exit port from said first chamber.
 39. Moduleaccording to claims 17, 33 and 37, characterized in that the connectorsand the support structure are positioned laterally with respect to themain body on one of said longer sides.
 40. Module according to claim 9,characterized in that the first and second half-part are specularlysymmetrical with respect to a longitudinal axis of the main body. 41.Apparatus for extracorporeal blood treatment comprising a body having onits surface a given number of pumps designed to cooperate with asuitable fluid distribution circuitry to be associated to the apparatus,at least one of said pumps being a blood pump designed to cooperate witha respective blood line of the distribution circuitry, characterized inthat the apparatus body defines on its surface a first zone having saidblood pump and at least a second zone opposite said first zone andhaving the other pumps.
 42. Apparatus according to claim 41,characterized in that at least one of said pumps is a feeding pump andis designed to cooperate with a respective feeding line for freshdialysis liquid of the distribution circuitry.
 43. Apparatus accordingto claim 42, characterized in that said second zone comprises at leasttwo half-parts place side by side, the feeding pump being placed in saidfirst half-part.
 44. Apparatus according to claim 41, characterized inthat in operating conditions the first zone of the apparatus body isplaced below the second zone of said body.
 45. Apparatus according toclaim 43, characterized in that in operating conditions the first andsecond half-part of the second zone of the apparatus body are placedside by side.
 46. Apparatus according to claim 43, characterized in thatsaid first and second half-part are specularly symmetrical. 47.Apparatus according to claim 41, characterized in that at least one ofsaid pumps is a suction pump designed to cooperate with a respectivedischarge line of the distribution circuitry.
 48. Apparatus according toclaim 47, characterized in that said second zone comprises at least twohalf-parts place side by side, the suction pump being placed in saidsecond half-part.
 49. Apparatus according to claim 41, characterized inthat at least one of said pumps is an infusion pump designed tocooperate with a respective infusion line of the distribution circuitry.50. Apparatus according to claim 49, characterized in that said secondzone comprises at least two half-parts place side by side, the infusionpump being placed in said first half-part.
 51. Apparatus according toclaim 41, characterized in that at least one of said pumps is anauxiliary pre-infusion pump designed to cooperate with a respectiveauxiliary pre-infusion line of the distribution circuitry.
 52. Apparatusaccording to claim 51, characterized in that said second zone comprisesat least two half-parts place side by side, the auxiliary pre-infusionpump being placed in said second half-part.
 53. Apparatus according toclaims 42, 47, 49 and 51, characterized in that said blood, feeding,discharge, infusion and auxiliary pre-infusion pumps are peristalticpumps.
 54. Apparatus according to claim 53, characterized in that eachperistaltic pumps comprises a moving arm rotating around a fulcrum, andan active element, fastened to the moving arm rotating with it,operating on at least a deformable tube length associated thereto. 55.Apparatus according to claim 54, characterized in that the moving arm ofthe blood pump is longer than that of other pumps.
 56. Apparatusaccording to claim 41, characterized in that it is designed to receivean integrated fluid treatment module in accordance with any of theclaims 1 to
 40. 57. Integrated fluid treatment module comprising:support element, a fluid distribution circuitry associated to thesupport element and comprising: at least a blood line, at least aportion of said blood line being secured to the support element anddefining at least a U-shaped tube length with respect to said supportelement, said tube length being designed to cooperate, when in use, witha respective pump; at least an intake line for fresh dialysis liquid, atleast a portion of said intake line for fresh dialysis liquid beingsecured to the support element and defining at least a tube lengtharranged as a U with respect to said support element, said tube lengthof the liquid intake line being designed to cooperate, when in use, witha respective pump, at least a discharge line for waste fluid, at least aportion of said discharge line for waste fluid being secured to thesupport element and defining at least a tube length arranged as a U withrespect to said support element, said tube length being designed tocooperate, when in use, with a respective pump, at least a fluidinfusion line, at least a portion of said fluid infusion line beingsecured to the support element and defining at least a tube lengtharranged as a U with respect to said support element, said fluidinfusion line being designed to cooperate, when in use, with arespective pump, characterized in that the support element has a firstzone to which the portion of the blood line is secured, and at least asecond zone opposite said first zone, the intake line for fresh liquid,the discharge line for a waste fluid and the fluid infusion line allbeing fastened on said second zone, and in that said second zonecomprises at least two half-parts placed side by side, at least the tubelength of the intake line for fresh liquid and at least the tube lengthof the fluid infusion line being secured to the first half-part. 58.Integrated fluid treatment module comprising: a support element, a fluiddistribution circuitry associated to the support element and comprising:at least a blood line, at least a portion of said blood line beingsecured to the support element and defining at least a U-shaped tubelength with respect to said support element, said tube length beingdesigned to cooperate, when in use, with a respective pump; other fluidlines fastened to the support element defining each a U-shaped tubelength with respect to said support element, each tube length beingdesigned to cooperate, when in use, with a respective pump,characterized in that the U-shaped tube length of the blood line islonger than the tube lengths defined by the other fluid lines. 59.Extracorporeal blood treatment apparatus comprising a body having on itssurface a given number of pumps designed to cooperate with a suitablefluid distribution circuitry to be associated to the apparatus, at leastone of said pumps being a blood pump designed to cooperate with arespective blood line of the distribution circuitry, characterized inthat the blood pump has a greater size than the other pumps.